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Randomised, Open-label, Active-controlled, Multicentre, Comparative Study to Evaluate the Safety and Efficacy of Ferric Maltol (Iron (III)-Maltol Complex) (ST10) Oral Suspension Compared to Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, Incorporating a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

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Trial Profile

Randomised, Open-label, Active-controlled, Multicentre, Comparative Study to Evaluate the Safety and Efficacy of Ferric Maltol (Iron (III)-Maltol Complex) (ST10) Oral Suspension Compared to Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, Incorporating a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Ferric maltol (Primary) ; Ferrous sulfate
  • Indications Iron deficiency anaemia
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms FORTIS

Most Recent Events

  • 24 Apr 2025 According to a Shield Therapeutics media release, Results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305), confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric suspension in children with iron deficiency anemia (IDA). The trial was the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA.
  • 09 Jan 2025 Status changed from recruiting to completed.
  • 18 Dec 2023 Planned End Date changed from 1 Sep 2023 to 1 Jul 2024.

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